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  • [지적재산권/IT] Partial Amendment to the Regulations on the Approval, Notification, and Evaluation of Quasi-Drugs
    • Competent Ministry : Ministry of Food and Drug Safety
    • Advance Publication of Legislation : 2018-07-30
    • Opinion Submission Deadline : 2018-09-30

(1) Reasons for Proposal

The Amendment aims to clarify the subject of safety and efficacy evaluation by reflecting the nature of paper items as quasi-drug products and reinforce the regulation on toxicity exemption in assessing the safety and efficacy of paper products, thereby improving and complementing a number of weaknesses that have emerged in the operation of the current system.

(2) Major Provisions

A. Clarify the subject of safety and efficacy evaluation (Article 21 (1) 1-2 newly inserted).

Quasi-drugs are currently waived from safety and efficacy evaluation if the active ingredients of a product are the same; however, for the quasi-drugs corresponding to No. 1 of the Designation of the Scope of Quasi-Drugs, whether a product is subject to safety and efficacy evaluation was determined according to the composition of the product (name of raw materials and intended use) because the effective ingredients are unclear; and therefore, this Amendment is to optimize the work of approval and evaluation by clearly reflecting the criteria in the regulations.

B. Clarify the range of countries selling the products, for which the toxicity data on paper items as quasi-drugs may be waived (Article 24 (2)).

For paper items as quasi-drugs, the toxicity data, among safety and efficacy evaluation data, are currently exempted where the document is submitted to prove that they are selling in more than two countries; however, the condition of the two countries is unclear, whereas the scope of other quasi-drug groups is clearly defined as more than two OECD countries; and, therefore, this Amendment is to secure the justification of toxicity data exemption and safety of product by clarifying the subject of toxicity data exemption.

C. Clarify the entries of raw material manufacturers of sanitary pads (Attached Table 2)

Currently, the name and location of the raw material manufacturer of the active ingredient shall be included in the quasi-drugs manufacturing method; however, for sanitary pads, the active ingredients are not clear, so that the names and locations of the manufacturers of the ingredients are recorded and managed instead; and therefore, this Amendment is to optimize the management of products by clearly reflecting the criteria in the regulations.

Regulatory effect assessment
  • 20180720 의약외품 품목허가・신고・심사 규정 일부개정고시 규제영향분석서.hwp [download]
Legislative proposal (draft)
  • 20180711 의약외품 품목허가・신고・심사 규정 일부개정고시_수정.hwp [download]